Product code FKO
- Device name
- Catheter, Peritoneal Dialysis, Single Use
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5630
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964514 | CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS | Corpak, Inc. | 1998-06-26 |
| K974570 | PERITONEAL DIALYSIS CATHETER CONNECTOR | Medigroup, Inc. | 1998-02-27 |
| K910787 | TITANIUM CONNECTOR (2 PART) | Accurate Surgical Instruments Co. | 1991-08-15 |
| K885037 | AMUKIN 50% - AIRSPRAY(R) | Bernard J. Cooney, P.A. | 1990-10-19 |
| K874650 | PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) | Quinton, Inc. | 1987-12-09 |
| K872221 | DIALY-NATE SET & DIALY-NATE CATHETER | Gesco Intl., Inc. | 1987-10-13 |
| K871730 | MODIFIED USE OF PULL-APART INTRODUCER SET | Quinton, Inc. | 1987-05-18 |
| K870472 | ACUTE PERITONEAL DIALYSIS KIT | Quinton, Inc. | 1987-02-25 |
| K860155 | PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 | Medical Components, Inc. | 1986-02-14 |
| K854966 | ACUTE PERITONEAL DIALYSIS CATHETERS | Thermedics, Inc. | 1986-01-09 |
| K845041 | CAPD STAGED CONNECTOR | Abbott Laboratories | 1985-02-21 |
| K813336 | LAZARUS-NELSON PERITONEAL LAVAGE TRAY | American Pharmaseal Div. Ahsc | 1981-12-18 |
| K812717 | NON-STERILE SHADOW-STRIPE CATHETER | Quinton, Inc. | 1981-10-19 |
| K811266 | QUINTON CATHETER FINGER GRIP | Quinton, Inc. | 1981-06-18 |
| K802954 | DRESSING CHANGE TRAY-MEDIUM | Associated Medical Products Co. | 1980-12-17 |
| K760544 | CATHETER, PERITONEAL DIALYSIS | Travenol Laboratories, S.A. | 1976-10-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10884521811164 | Ritus | Mozarc Medical US LLC | 2026-04-20 |
| 10885403108327 | n/a | CAREFUSION 2200, INC | 2017-06-12 |
| 50885403108325 | n/a | CAREFUSION 2200, INC | 2017-06-12 |
| 10884521024298 | Argyle | Mozarc Medical US LLC | 2016-09-24 |
| 10884521024311 | Argyle | Mozarc Medical US LLC | 2016-09-24 |
| 20884521024318 | Argyle | Covidien LP | 2016-09-24 |
| 20884521024301 | Argyle | Covidien LP | 2016-09-24 |
| 20884521024295 | Argyle | Covidien LP | 2016-09-24 |
| 20884521024288 | Argyle | Covidien LP | 2016-09-24 |
| 10884521024281 | Argyle | Mozarc Medical US LLC | 2016-09-24 |
| H67140005270 | DIALY-NATE | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67140005670 | DIALY-NATE | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67140005570 | DIALY-NATE | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67140005470 | DIALY-NATE | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67140005370 | DIALY-NATE | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67140005170 | DIALY-NATE | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67140005070 | DIALY-NATE | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| 20898021000062 | Alcavis 50 | ANGELINI PHARMA INC. | 2016-08-29 |
| 00898021000068 | Alcavis 50 | Angelini Pharma Inc. | 2016-08-29 |
| 00884450170021 | Flex-Neck® | Merit Medical Systems, Inc. | 2015-10-30 |
| 10884450170028 | Flex-Neck® | Merit Medical Systems, Inc. | 2015-10-30 |
| 00852250006017 | Lifemed Acute Tenckhoff Peritoneal Catheter | LIFEMED OF CALIFORNIA | 2015-10-06 |
| 10852250006014 | Lifemed Acute Tenckhoff Peritoneal Catheter | LIFEMED OF CALIFORNIA | 2015-10-06 |
| 00852250006079 | Lifemed Pediatric Acute Tenckhoff Peritoneal Catheter | LIFEMED OF CALIFORNIA | 2015-10-06 |